Adverse Drug Events Reporting Process

Introduction

SME: Director of Pharmacy
Last Review Date: 1/16/13

Definitions

Adverse Drug Event (ADE): An adverse drug event is “an injury resulting from the use of a drug. Under this definition, the term ADE includes harm caused by the drug (adverse drug reactions and overdoses) and harm from the use of the drug (including dose reductions and discontinuations of drug therapy).”   Adverse Drug Events may results from medication errors but most do not.

Adverse Drug Reaction (ADR): Any response to a drug that is harmful or unintended and that occurs at doses used in man for prophylaxis, diagnosis, or therapy, excluding failure to accomplish the intended purpose. This does not include side effects (expected, well known reactions resulting in little or no change in patient management) or any drug effects, which may occur when the drug is given inappropriately. Allergic and idiosyncratic reactions are also considered ADRs

Medication Error (ME):   Medication errors are mishaps that occur during prescribing, transcribing, dispensing, administering, adherence, or monitoring a drug. Examples of medication errors include misreading or miswriting a

prescription. Medication errors that are stopped before harm can occur are sometimes called “near misses” or  more formally, a potential adverse drug event. Not all prescribing errors lead to adverse outcomes. Some do not cause harm, while others are caught before harm can occur (“near-misses”).

Medication Use Process: The cycle of medication management that includes ordering, dispensing, administering, and monitoring. The cycle also includes all systems supporting these processes.

GENERAL PROCEDURE

All actual and potential adverse drug event occurrences shall be recorded on the UT-HCPC intranet webform by nursing or pharmacy staff or on the adverse drug reaction form by physicians utilizing the Sunrise clinical manager program. In the event of a computer failure, the hard copy ADE Reporting Form is available at each nursing unit when the computer system is down. This form must be completed with specific, factual, and objective information so that the true magnitude and nature of circumstances can be studied.

When the ADE intranet form is completed online, it will automatically be routed to the appropriate managers for acknowledgement. When the Adverse Drug Reaction form is complete in Sunrise, the patient chart will be flagged with information on the medication suspected causing the ADR.

Actual or suspected adverse drug reactions must also be documented in the progress notes of the patient’s chart.

As a private and confidential document, any printed version of the ADE Form must not be:

i. Left in a patient’s room or shared with personnel other than those specified by the procedure below

ii. Referenced or placed in a patient’s chart or an employee’s file

iii. Copied

A healthcare professional who witnesses or first discovers that an adverse drug event (ADE) has occurred shall record the information in accordance with the procedures section of this document. All recorded ADEs shall be reported to the Pharmacy and Therapeutics Committee,  the Safety Committee, and the Performance Improvement Committee. Intentional failure to report a known adverse drug event may be investigated and appropriate action taken.

REPORTING PROCEDURES FOR SPECIFIED INDIVIDUALS

Procedure for Healthcare Worker Nurse:

1. Identifies suspected adverse drug event

2. Documents pertinent diagnostic information on the medical record for adverse events resulting in temporary or permanent patient harm.

3. Contacts Physician immediately if patient care is affected.

4. Completes Adverse Drug Event Form located on the intranet under Webforms. In the event  the computer system is down the nurse will fill out the ADE form located on the nursing unit and forward to the Nursing Supervisor/Manager.

Procedure for Healthcare Supervisor:

1. Reviews and completes Adverse Drug Event Form via computer.

2. Provides follow-up and corrective actions

3. Forward completed ADE form to Pharmacy.

Procedure for Physician utilizing Sunrise to record ADRs:

1. Assesses patient for suspected adverse drug event resulting in temporary or permanent patient harm.

2. Determines and orders measures as appropriate to resolve the suspected adverse drug reaction:

a. Diagnostic testing

b. Monitoring of vital signs

c. Administration of medications, antidotes, intravenous fluid and supportive therapy

Procedure for Pharmacy Service:

1. Pharmacy Reviews adverse drug event form for completeness and investigates immediately.

2. Contacts Nurse Manager /Supervisor and Prescribing Physician, immediately if patient care is affected.

3. All ADE paper forms will be filed within the Pharmacy Department for record keeping.

4. ADEs with index level > 4 will be drilled down by all the disciplines involved (Pharmacy, Nursing and Medicine) with an action plan to prevent further ADE’s.

5. Pharmacy will trend and report findings for educational purposes to:

i. Pharmacy & Therapeutics (P&T) Committee

ii. The Safety Committee

iii. Performance Improvement Committee

iv. Medical Executive Committee

v. Nursing Director

6. Maintains record of reported adverse events for a period not less than 2-years from the date reported to the Pharmacy & Therapeutic Committee. 

7.  Pharmacy will report adverse drug reactions to the Food and Drug Administration when appropriate via the MedWatch reporting system.

IV. ADE/ADR INVESTIGATION AND ANALYSIS

a. All completed ADE forms will be entered into a database consistent with the ADE form.

b. All ADEs will be:

i. Verified for completeness and accuracy by Pharmacy

ii. Routed to related health care professional and administrators

iii. Investigated by the department involved

iv. Investigated for root cause (sentinel events)

c. The ADE database will minimally be trended by:

i. Cause or potential cause

ii. Drug

iii. Patient Outcome

iv. Units

v. Persons involved

vi. Benchmarks

vii. Variance

d.  A  quarterly report presenting trended and aggregated data will be presented to The Safety Committee for review.

e. The Plan-Do-Check-Act approach will be applied to improve identified deficient processes and outcomes through performance improvement projects.

f. Quarterly reports will be forwarded to Pharmacy and Therapeutics with recommendations for follow-up actions

g. Annual evaluation of the Medication Use Process will be performed based on the outcomes identified

ADE Variance Index and Patient Outcome

Definitions for Types of Errors or Occurrences:

Documented Allergy: Patient had a documented allergy to an administered medication or another medication in its class

Drug/Drug Interaction: Dispensing or administering a medication that has potential for drug /drug interaction

Drug/nutrient interaction: Drug administered with food or drink that alters its absorption or metabolism

Omission: Failure to administer an ordered dose; excludes patient’s refusal and a clinical decision or other valid reason for not administering

Therapeutic Duplication: The unintentional or unnecessary use of multiple agents from the same chemical family or therapeutic class.

Wrong Dose: A dose that is greater than or less than the amount ordered by the prescriber or duplicate doses

Wrong Medication: A medication other than one authorized by the prescriber was dispensed or administered to patient

Wrong Time: A scheduled dose administered outside HCPC acceptable predetermined time interval. A deferral in the administration of a prescribed medication; excludes patient’s refusal, a clinical decision to delay or other valid reason for not administering. This differs from omission in that a dose is not actually missed.

Wrong Frequency: A medication given at an interval different than prescribed or at a prescribed frequency outside of practice standards or guidelines

Wrong Patient: A medication prescribed for the wrong patient or given to a patient different than prescribed.

Incomplete medication order/prescription: An order or prescription that does not contain required components for processing (e.g. dose, route, dosing instructions, physician signature, etc.)

Definitions for Categories of Error:

Prescribing: The inappropriate selection of a drug (based on indication, contraindications, known allergies, existing drug therapy, and other factors); dose; dosage form; quantity; route of administration; concentration; rate of administration; or inappropriate or inadequate instructions for use of a medication ordered by a physician or other authorized prescriber.

Dispensing: The failure to dispense a medication upon physician order or within a specified period of time from receipt of the medication order or reorder ; dispensing the incorrect drug, dose, dosage form; failure to dispense correct amount of medication; inappropriate, incorrect, or inadequate labeling of medication; incorrect or inappropriate preparation, packaging, or storage of medication prior to dispensing; dispensing of expired, improperly stored, or physically or chemically compromised medications.

Administration: Failure to administer a drug in the prescribed manner or administration of a drug utilizing incorrect or inappropriate techniques.

Date of Report: ______________________  Reporting Individual (Circle one. Do not include names)

                                                                                    RN      RPh     MD      Other: ________________

Date / Time of Notification: ____________  Date / Time of Error: ____________________________

ADVERSE DRUG REACTIONS (PART I AND II)

INSTRUCTIONS: Any possible adverse drug reaction must be documented in the patient’s medical record. After completion of Part I and II of this form, forward to the Pharmacy. After review, Pharmacy submits the form to Data Management.

Suspected Drug(s):___________________________________________________________________

Dose of major drug suspected of causing adverse drug event:_________________  Route: __________

Type of report             ADR                           Med Error

MEDICATION ERRORS (PART III AND IV

** Physician findings and orders (for Level 1 through Level 6) __________________________________

______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Signature / Date / Time:  Not Needed Below

MD: ________________________________________________________________________________

Nurse Manager: _______________________________________________________________________

Pharmacy: ____________________________________________________________________________

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